Radiation Sterilization for Medical Devices
This 3½ day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. The course examines:
- FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance
- Scientific theory and principles of radiation sterilization
- The new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards
- Integration of industry standards with the Quality System regulation
- Sterility Assurance Levels (SALs)
- Auditing processes for contract laboratories and sterilizers
- Radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
Format
This course is designed to be highly interactive between faculty and participants and will include relevant real life examples and “hands-on” exercises from a broad spectrum of medical device products.
Dates & Hotels
| DATES | LOCATION | PHONE & RATES |
| October 8-11, 2013 | San Francisco Marriott Fisherman's Wharf 1250 Columbus Avenue San Francisco, CA 94135 website |
800-525-0956 | 415-775-7555 $204 single/double Rate through 9/10/2013 |
| NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
Program
At-A-Glance
| DAY ONE 8:00 AM-5:00 PM |
| — Introduction — Overview of ANSI/AAMI/ISO 11137-1 — Microbiological Quality Tests — Contract Sterilizers and Laboratories — Sterility Assurance Levels — Process Definition — Maximum Acceptable Dose — FDA Perspective — FDA's Expectations and Guidance |
| DAY TWO 8:00 AM-5:00 PM |
| — Process Definitions — Sterilization Dose; Sterilization Dose: Method 1; and Sterilization Dose: Method VDmax — Dosimetry — FDA Perspective — Responding to Inspectional Observations (483's) and Warning Letters — Sterilization Equipment Validation |
| DAY THREE 8:00 AM-5:00 PM |
| — Gamma Radiation — Processing and Validation — Electron Beam and X-Ray Radiation — Processing and Validation — Routine Processing — FDA Perspective — Purchasing Controls — Process Definition — Sterilization Dose: Method 2 |
| DAY FOUR 8:00 AM-12:00 PM |
| — Maintenance of Validation — Changing Radiation Sterilization and/or Manufacturing Sites — FDA Perspective — Sterilization Inspectional Observations |
Who Should Attend
This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.
Faculty
In consultation with industry, government leaders, and educational experts, this course was developed to meet the medical device industry’s need for a better understanding of radiation sterilization principles, standards, and methods. The course will be taught by a mix of independent experts and industry representatives experienced in radiation sterilization. Instructors will provide a balanced presentation of radiation sterilization principles and practices as described in topics above.
Course Materials
Participants will receive the following:
- ANSI/AAMI/ISO 11137-1:2006(R)2010 Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
- ANSI/AAMI/ISO 11137-2:2006 Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose;
- ANSI/AAMI/ISO 11137-3:2006(R)2010 Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects;
- Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.
Fee and Registration
Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $1935 |
| AAMI individual members | $2035 |
| Nonmembers | $2435 |
| Government employees | $635 |